FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
Nationwide distributionDrugs
What this means
Hair was found in vials of Xylocaine (lidocaine HCl Injection, USP) 1% supplied by Fresenius Kabi. The affected product is a multiple-dose vial medication used for local anesthesia. This contamination could pose a risk if the injection is administered without detection.
- Check your facility's inventory for Lot #6130235 with expiration date 02/2027 (NDC Vial: 63323-485-01).
- Visually inspect vials for any particulate matter before use.
- Do not use affected vials; contact your supplier or Fresenius Kabi for replacement or credit.
- Report any adverse events or injuries to the FDA MedWatch program.
The agency's original wording
Hazard
Presence of Particulate Matter: Hair was found in products
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within in the USA
Affected count
93,250 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0728-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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